Apparatus and method for performing a bypass procedure in a digestive system

ABSTRACT

Surgical instrumentation and methods for performing a bypass procedure in a digestive system incorporate laparoscopic techniques to minimize surgical trauma to the patient. The instrumentation includes an outer guide member dimensioned for insertion and passage through an esophagus of a patient and defining an opening therein extending at least along a portion of the length of the outer guide member, an elongate anvil delivery member at least partially disposed within the opening of the outer guide member and being adapted for longitudinal movement within the outer guide member between an initial position and an actuated position and an anvil operatively engageable with the delivery member. The anvil includes an anvil rod defining a longitudinal axis and an anvil head connected to the anvil rod. The anvil head is at least partially disposed within the opening of the outer guide member when in the initial position of the delivery member and is fully exposed from the distal end of the outer guide member upon movement of the delivery member to the actuated position.

BACKGROUND

1. Field of the Disclosure

The present disclosure relates generally to an apparatus and method fortreating obesity, and, in particular, to an apparatus and method forperforming a laparoscopic bypass procedure in a digestive system.

2. Description of the Related Art

Morbid obesity affects from about 3% to 5% of the population. Theseverely obese are at significantly greater risk of premature death,heart disease, stroke, diabetes mellitus, cancer, pulmonary diseases,orthopaedic complications and accidents. The obese are also subject todiscrimination in society, the workplace, etc.

Several methods for treatment of morbid obesity include diets, pills,and other weight-reducing plans. Mechanical devices for insertion intothe stomach, e.g., gastric balloons, to at least partially occupy thestomach have also been utilized. These approaches, however, aregenerally effective for a limited period of time. In addition, over 95%of those participating in such approaches regain their original weight,and, in many instances, gain additional weight.

Methods for treating obesity proven effective over the long term includesurgery to restrict the amount of food consumed at one sitting and tochange the digestive process such that less of the food consumed will beabsorbed into the body. These procedures are collectively known asBariatric Surgery and include Gastroplasty, Gastric Banding and GastricBypass.

Gastroplasty incorporates separating the stomach into two pouch areas,e.g., an upper pouch and a lower pouch, through stapling. A smallopening or stoma is then formed through the row of staples. Thus, theconsumed food collects within the upper pouch and passes through thestoma and into the lower pouch at a reduced rate thereby giving asensation of fullness to the individual to limit the amount of foodintake. Disadvantages of this procedure include expansion of the upperpouch and the stoma which thereby minimizes long term effectiveness ofthis procedure.

In Vertical Banded Gastroplasty (VBG), an upper gastric pouch is formedwithin the stomach by applying a vertical row of staples. A band (e.g.,a Marley mesh) is applied about the stomach adjacent the staple line toprevent dilation of the outlet port D extending from the upper pouchinto the remaining portion of the stomach. The Vertical BandedGastroplasty (VBG) method, however, is subject to certain disadvantagesincluding problematic post-operative healing, high rate of complicationssuch as wound infection, pulmonary emboli, gastric perforation, gallbladder stones, etc.

Gastric Bypass combines the elements of intestinal rearrangement with asmaller stomach pouch. More particularly, with this procedure, thestomach is divided into an upper pouch and a lower pouch. The upperpouch, which receives the consumed food, is greatly reduced in capacityand is directly connected to the small intestine. However, conventionalgastric bypass techniques involve invasive surgical approaches whichhave a deleterious effect on patient recovery and down time.

In recent years, minimally invasive surgical techniques have beendeveloped to reduce trauma to the patient and minimize recover time.Such minimally invasive procedures include endoscopy, laparoscopy,colonoscopy, etc. and typically require elongated narrow instruments toperform surgery on organs, tissues and vessels far removed from theincision. Laparoscopic procedures are performed in the interior of theabdomen through a small incision, e.g., through a tube or cannulainserted through a small entrance incision in the abdominal cavity. Todate, however, satisfactory laparoscopic approaches and instrumentationfor a bypass procedure in a digestive system have not been developed.

SUMMARY

Accordingly, the present disclosure is directed to surgicalinstrumentation and methods for performing a bypass procedure in adigestive system, which incorporates laparoscopic techniques to minimizesurgical trauma to the patient. In one preferred embodiment, anapparatus for facilitating performance of a gastroplasty procedure,includes an outer guide member dimensioned for insertion and passagethrough an esophagus of a patient and defining an opening thereinextending at least along a portion of the length of the outer guidemember, an elongate anvil delivery member at least partially disposedwithin the opening of the outer guide member and being adapted forlongitudinal movement within the outer guide member between an initialposition and an actuated position and an anvil operatively engageablewith the delivery member. The anvil includes an anvil rod defining alongitudinal axis and an anvil head connected to the anvil rod. Theanvil head is at least partially disposed within the opening of theouter guide member when in the initial position of the delivery memberand is fully exposed from the distal end of the outer guide member uponmovement of the delivery member to the actuated position.

The anvil head may be pivotally mounted to the anvil rod and movablebetween a non-operative position and an operative position. A pivotmember at least partially disposed within the outer guide member andoperatively connected to the anvil head moves between first and secondpositions thereof to cause corresponding movement of the anvil headbetween the respective non-operative and operative positions. The pivotmember is normally biased to the second position thereof. Means forreleasably locking the pivot member in the first position may beprovided. Preferably, the pivot member includes a locking surfaceengageable with a corresponding locking surface of one of the deliverymember and outer guide member to releasably lock the pivot member in thefirst operative position. Preferably, the pivot member includes amanually operable handle which defines the locking surface of the pivotelement. The pivot member is preferably dimensioned to extend proximallybeyond the insertion member to be grasped by the surgeon.

Alternatively, the anvil may be pivotally mounted to the deliverymember. An elongate pivot member at least partially disposed within theouter guide member is operatively connected to the anvil and is movableto cause corresponding pivotal movement of the anvil through a pivotalrange of motion.

A method for performing a bypass procedure in a digestive system is alsodisclosed. The method includes the steps of introducing an anvil throughan esophagus of a patient and into a first digestive tissue portion,inserting an anastomosis instrument into a second digestive tissueportion displaced from the first digestive tissue portion, manipulatingthe anvil from a proximal location to position the anvil at a desiredorientation with respect to the anastomosis instrument, connecting theanvil to the anastomosis instrument and firing the anastomosisinstrument to connect the first and second digestive tissue portions.

In the alternative, a method for performing a bypass procedure in adigestive system includes the steps of isolating an upper stomachportion of the stomach of a patient, resecting the bowel to define abowel portion disconnected from the stomach, and connecting the bowelportion and the upper stomach portion. The step of connecting ispreferably performed with an end to end anastomosis instrument. Themethod may further include the step of introducing an anvil adapted foruse with the anastomosis instrument through an esophagus and into theupper stomach portion and introducing an end to end anastomosisinstrument into the bowel portion. The anvil and the end to endanastomosis instrument are connected, and the end to end anastomosisinstrument is fired to connect the bowel portion and the upper stomachportion.

The step of isolating may include positioning a linear staplerinstrument about the stomach and firing the linear stapler to isolatethe upper stomach portion with resect to the remainder of the stomach.Similarly, the step of resecting includes positioning a linear staplerabout the small bowel and firing the linear stapler. The linear staplermay have a knife blade associated therewith and wherein upon firing theknife blade is actuated to resect the bowel to define the bowel portion.

In an alterative, the method for performing a bypass procedure in adigestive system includes the steps of accessing digestive tissueportions of a digestive system, advancing an anvil through the esophagusand into the first digestive tissue portion, inserting an anastomosisinstrument into the second digestive tissue portion, connecting theanvil with the anastomosis instrument and firing the anastomosisinstrument to connect the first and second digestive tissue portions,disconnecting the anvil from the anastomosis instrument, and withdrawingthe anvil through the esophagus.

The method may further include the step of manipulating the anvil from aproximal location outside the body to facilitate connecting of the anvilwith the anastomosis instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the disclosure are described herein withreference to the drawings wherein:

FIG. 1 is a perspective view of the apparatus for facilitatingperformance of a gastric bypass procedure in accordance with theprinciples of the present disclosure;

FIG. 2 is a perspective view with parts separated of the apparatus ofFIG. 1, illustrating the insertion member and the anvil delivery memberof the apparatus;

FIG. 3 is a perspective view with parts separated of the anvil deliverymember;

FIG. 4 is a side cross-sectional view of the apparatus;

FIG. 5 is a perspective view of an end to end anastomosis utilized toperform the gastric bypass procedure;

FIG. 6 is a perspective view of a endoscopic stapling instrumentutilized to perform the gastric bypass procedure;

FIGS. 7-16 are views illustrating the sequence of steps in performing alaparoscopic gastric bypass procedure in accordance with one preferredmethod of the present disclosure;

FIG. 17 is a view of a portion of a-digestive system with staple andresection lines in connection with alternate bypass procedures to beconducted in accordance with the present disclosure;

FIG. 18 is a perspective view of an alternate embodiment of theapparatus of FIG. 1;

FIG. 19 is a perspective view of the apparatus of FIG. 18 in an actuatedposition;

FIG. 20 is a perspective view of another alternate embodiment of theapparatus of FIG. 1;

FIG. 21 is a perspective view of the distal end of the apparatus of FIG.20 illustrating the anvil in an inoperative position;

FIG. 22 is a perspective view of the distal end of the apparatus of FIG.20 illustrating the anvil in an operative position;

FIG. 23 is a side plan view of an alternate embodiment of the apparatusof FIG. 1;

FIG. 24 is an axial view of the apparatus of FIG. 23;

FIG. 25 is a side cross-sectional view of the apparatus;

FIG. 26 is a side plan view of the distal end of the apparatusillustrating the anvil in an inoperative position;

FIG. 27 is a view similar to the view of FIG. 26 illustrating the anvilin an operative position;

FIG. 28 is a side cross-sectional view of the distal end of theapparatus;

FIG. 29 is a perspective view of an alternate embodiment of theapparatus of the present disclosure illustrating the catheter guide,delivery apparatus, and mounted anvil assembly;

FIG. 30 is an enlarged perspective view of the anvil assembly mounted tothe catheter guide and delivery apparatus;

FIG. 31 is a perspective view illustrating connection of a suture unitof the anvil assembly to the catheter guide;

FIGS. 32A-32B are side plan and cross-sectional views of the anvil rodof the anvil assembly;

FIGS. 33A-33B are cross-sectional and side plan views of the anviladapter;

FIG. 34 is a perspective view illustrating mounting of the anvil rod tothe anvil adapter;

FIG. 35 is a cross-sectional view of the anvil assembly and mountedanvil adapter;

FIGS. 36-39 are views illustrating the sequence of steps in performingthe laparoscopic gastric bypass procedure with the instruments of FIG.29;

FIG. 40 is a perspective view of another alternate embodiment of thepresent disclosure illustrating the delivery apparatus and mounted anvilassembly;

FIG. 41 is a perspective view with parts separated of the apparatus ofFIG. 40;

FIG. 42 is a side cross-sectional view of the apparatus in an initialposition;

FIG. 43 is a view similar to the view of FIG. 42 illustrating the pivotmechanism actuated corresponding to the pivoted position of the anvilhead;

FIG. 44 is a view similar to the view of FIG. 42 illustrating therelease mechanism actuated to release the anvil from the anastomosisinstrument;

FIGS. 45-46 are perspective views of the light guide which is attachableto the anvil assembly;

FIG. 47 is a perspective view with parts separated of the light guide;

FIG. 48 is a side cross-sectional view of the light guide;

FIG. 49 is a perspective view of an anvil adapter depicted mounted to ananvil assembly;

FIG. 50 is a cross-sectional view of the anvil adapter taken along thelines 50-50 of FIG. 49;

FIG. 51 is an enlarged isolated view depicting the relationship of theplunger and jaw mechanism of the anvil adapter;

FIGS. 52-53 are cross-sectional views of the anvil adapter illustratingactivation of the release mechanism to release the anvil adapter fromthe anvil assembly; and

FIGS. 54-55 are enlarged perspective views of the jaw assembly of agrasping instrument suitable for grasping the anvil rod.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The preferred embodiments of the method and instrumentation disclosedherein are discussed in terms of bypass procedures in the digestivesystem, and instrumentation utilized to carry-out the procedures.Although described specifically in connection with a laparoscopicapproach, it is envisioned that the disclosure is applicable to aconventional open approach as well.

The following discussion will include a description of each instrumentutilized in performing a digestive system bypass procedure followed by adescription of preferred methods for bypass utilizing theinstrumentation in accordance with the present disclosure.

In the discussion which follows, the term “proximal”, as is traditional,will refer to the portion of the structure which is closest to theoperator, while the term “distal” will refer to the portion which isfurthest from the operator.

Referring now to FIGS. 1-4, there is illustrated one preferredembodiment of the apparatus for performing a laparoscopic digestivebypass procedure in accordance with the principles of the presentdisclosure. Apparatus 10 includes generally two components, namely,outer guide member 12 and anvil delivery member 14 which is at leastpartially disposed within the outer guide member 12. Guide member 12 isfabricated from a flexible material such that the guide member 12 maybend or flex as required during deployment of the anvil delivery member14. In a preferred embodiment, guide member 12 comprises an elastomericmaterial. As best depicted in FIG. 4, guide member 12 includes aninternal opening or cavity 16 which accommodates at least a portion ofdelivery member 14. Guide member 12 defines longitudinal axis “a” andhas proximal end-portion 18, distal end portion 20 and intermediateportion 22 disposed between the proximal and distal end portions 18, 20.Intermediate portion 22 defines an internal dimension 22 a which islarger than both the respective internal dimensions 18 a, 20 a of theproximal end portion 18 and the distal end portion 20. Intermediateportion 22 also includes an internal groove 24 defined therein (FIG. 4).Preferably, each of the proximal and distal end portions 18, 20 of guidemember 12 gradually taper in linear relation to intermediate portion 22as shown. Distal end portion 20 of guide member 12 further defines anaxial opening 26. Slits 28 permit the guide member 12 to flare outwardlyto enlarge the effective size of opening 26.

With particular reference to FIGS. 2-4, anvil delivery member 14includes elongated support member 30 and anvil 32 which is supported atthe distal end portion of the support member 30. Support member 30includes elongate member 34, pivot block support 36 mounted to theelongate member 34 by pin 38 and pivot block 40 which is connected tothe pivot block support 36 by pin 42. Although shown as severalcomponents, it is appreciated that support member 30 can be manufacturedas a monolithic unit as well. Elongate member 34 is preferablysufficient in length and relatively flexible to extend from the stomachthrough the esophagus of the patient and out the oral cavity to begrasped by the surgeon.

Anvil 32 is intended for use with a circular or end-to-end anastomosisinstrument as will be discussed. Anvil 32 includes anvil head 44 andanvil rod 46 extending from the anvil head 44. Generally, anvil head 44includes a plurality of recesses which are adapted to form and closestaples ejected from the circular anastomosis instrument. Anvil rod 46engages corresponding mounting structure of the circular anastomosisinstrument to mount anvil 32 to the instrument. Anvil 32 furtherincludes pivot head 48 which pivotally connects to pivot block 40through pin 50 to permit the anvil 32 to pivot through at least apredetermined range of pivotal motion. In a preferred embodiment, anvil32 is pivotable through a 90° range of motion in one direction relativeto the longitudinal axis with the range of motion being restricted byengagement of shelf 52 of pivot head 48 and pivot block 40 (see FIG. 4).One anvil suitable for the purposes of the present disclosure isdisclosed in commonly assigned U.S. Pat. No. 5,718,360 to Green et al.,the contents of which are incorporated herein by reference.

As best depicted in FIGS. 3-4, anvil delivery member 14 further includespivot rod 54 which extends through guide member 12 and engages anvilhead 44 of anvil 32 as shown. In a preferred arrangement, pivot rod 54includes a hooked portion 56 which engages a corresponding dimensionedreceiving groove 58 disposed within anvil head 44. Other means forconnecting anvil head 44 and pivot rod 54 are envisioned as well. Pivotrod 54 is sufficient in length to extend from the stomach through theesophagus to be manipulated by the surgeon. Pivot rod 54 islongitudinally moveable between a retracted position and an extendedposition to selectively pivot anvil 32 at desired orientations.

In the assembled condition of anvil delivery member 14 within guidemember 12, the outer margin of anvil head 44 is received within internalgroove 24 of the guide member 12 to retain anvil 32 at the desiredposition mounted within the guide member 32. It is appreciated thatgroove 24 may be eliminated whereby anvil 32 may be fixed within guidemember 12 by frictional engagement of anvil head 44 with the inner wallsurface of the guide member 12.

Referring now to FIGS. 5-6, there is illustrated additionalinstrumentation utilized to perform the method in accordance with theprinciples of the present disclosure. FIG. 5 illustrates a circular orend to end anastomosis instrument. This instrument 100 is marketed underthe name PREMIUM CEEA™ manufactured by U.S. Surgical Corporation, ofNorwalk, Conn. and is the subject of commonly assigned U.S. Pat. No.5,119,983, the contents of which are incorporated herein by reference.This instrument 100 includes an elongated shaft 102 having a handleportion 104 at a proximal end to actuate the instrument and a stapleholding component 106 disposed at a distal end. An anvil component suchas anvil 32 described above is mountable to the distal end. Opposed endportions of the organs to be stapled are clamped between the anvil head44 and the staple holding component 106. The clamped tissue is stapledby driving one or more staples from the staple holding component 106 sothat the ends of the staples pass through the tissue and are clinched bythe anvil head 44. In some applications of the circular anastomosisprocedure, the anvil rod 46 with attached anvil head 44 is mounted tothe distal end of the shaft 102 prior to insertion of the instrumentinto the tissue to be anastomised. However, in other applications and inaccordance with the preferred method of the present disclosure, it ispreferable-to utilize a detachable anvil 32 which may be mounted to theinstrument subsequent to positioning of the instrument and the anvilcomponent within their respective tissue sections. In such instances,the stapling instrument and the anvil 32 are separately applied to theoperative site. Each tissue section is then secured to their respectiveanvil 32 or staple holding component 106 by a purse string. The anvil 32is mounted to the surgical instrument by inserting anvil rod 46 of theanvil 32 within the distal end of the instrument so that a mountingmechanism within the instrument securely engages the rod 46.

FIG. 6 illustrates an endoscopic linear surgical stapling apparatusmarketed under the name ENDO GIA™ manufactured by U.S. SurgicalCorporation of Norwalk, Conn. and is the subject of commonly assignedU.S. Pat. No. 5,894,979, the contents of which are incorporated hereinby reference. This instrument 200 is adapted to place a plurality oflongitudinal or linear rows of staples and may further include a knifefor making an incision in body tissue between the rows of staples. Theinstrument 200 includes a frame 202 and an elongated tubular member 204mounted to the frame 202. Mounted to the distal end portion of thetubular member is a cartridge assembly 206 which houses a plurality ofrows of staples. An anvil 208 is pivotably movable relative to thecartridge assembly 206 to position tissue therebetween. Upon activation,the staples are fired to be clinched by the anvil 208 while the knifesevers the tissue between the adjacent rows of staples.

In FIGS. 7-16, the disclosure describes methods for performing a bypassprocedure in a digestive system that is representative of accessing,preferably, laparoscopically, and connecting a first and a seconddigestive system tissue portion. The digestive system or tract asdefined herein includes the mouth, pharynx, esophagus, stomach, duodenumand colon.

Referring now to FIGS. 7-16, by way of example, there is illustrated thepreferred method for performing the laparoscopic gastric bypassprocedure utilizing the aforedescribed instrumentation in accordancewith the principles of the present disclosure. Initially, the peritonealcavity is insufflated with insufflation gases which are introducedthrough a peritoneum needle of an insufflation apparatus, thus,distending the peritoneal lining and providing enhanced access therein.With reference now to FIG. 7, endoscopic linear stapling instrument 200of FIG. 6 is introduced through a trocar “t” accessing the abdominalcavity. The instrument 200 is manipulated to position an upper portionof the stomach between the anvil 208 and the cartridge assembly 206. Theinstrument 200 is fired a first time whereby a first plurality of linearrows of staples are applied to the stomach portion at one angularorientation and then fired a second time at a second angular orientationto apply a second row of staples. As depicted in FIGS. 7-8, staplinginstrument 200 preferably is arranged with respect to the esophagealtract to form a staple line S₁ which extends generally upwardly from theright side of the stomach to the left side (left to right with respectto the drawing). A knife blade incorporated within the instrument 200removes or severs the tissue between adjacent rows of the staple lineS₁. Thus, instrument 200 applied in the above-described manner forms anisolated upper stomach section “u” detached from the remaining lowersection “l” of the stomach with both the upper and lower stomachsections “u, l” being closed by respective stapled rows S_(1a) andS_(1b) (FIG. 8). Alternatively, it is envisioned that the upper stomachsection “u” may remain attached to the remaining stomach portion by useof stapling instrument 200 which is devoid of a knife blade.

With reference again to FIG. 7, the linear stapling instrument 200 isthen positioned adjacent the small bowel through a trocar “t” in thelower part of the abdomen. Preferably, the instrument 200 is positionedadjacent an intermediate portion of the small bowel approximately 5-15inches from the duodenum “d”. The instrument 200 is fired to applystaples to form a staple line S₂ and preferably incise the bowel portionto thereby form a first bowel portion “b₁” connected to the stomach anda second bowel portion “b₂” which is connected to the remainder of theintestinal tract. The ends of the first and second bowel portions “b₁”,“b₂” are closed with respective linear rows of staples S_(2a) and S_(2b)(FIG. 8).

Referring particularly to FIG. 8, apparatus 10 is inserted within theesophagus “e” of the patient and advanced in the direction “A” withinthe now formed upper stomach portion “u”. The small bowel portion “b₂”is manipulated towards the upper stomach section “u”. Preferably, aconventional grasping instrument introduced through trocar sleeve “t”accessing the stomach is utilized to manipulate the bowel portion “b₂”to the desired position. The circular anastomosis instrument 100 ( FIG.5) is inserted through the trocar “t” positioned adjacent the upperstomach portion “u” and positioned within a previously formed opening“o” in the bowel portion “b₂” made preferably with a conventionallaparoscopic resecting instrument inserted within the trocar. The distalend of the circular anastomosis instrument 100 is thereafter advancedwithin the opening “o” such that the staple holding component 106 isdisposed within the lumen of the bowel portion “b₂”.

With reference now to FIGS. 9-10, anvil 32 is manipulated and thenpivoted by advancing pivot rod 54 from the position shown in FIG. 9 tothe position shown in FIG. 10, as desired, to position anvil rod 46 at adesired orientation for connection to instrument 100. As indicatedabove, anvil 32 is pivotal through an approximately 90° range of motionwhile guide member 12 is sufficiently flexible to permit such pivotalmovement. As appreciated, guide member 12 protects the interior of thestomach from the anvil during pivotal movement of anvil 32 relative tothe support member 30.

With reference now to FIGS. 11-12, support member 30 of instrument 10 islongitudinally advanced to advance anvil 32 within guide member 12 toexpose the end portion of anvil rod 46 of anvil 32 from the guide member12. During such movement, slits 28 in the outer wall of guide member 12(FIG. 2) permit the outer wall to deflect outwardly to enable anvil rod46 to pass through opening 26. Thereafter, anvil rod 46 can be graspedwith conventional forceps inserted through a trocar accessing the cavityand advanced through an opening “o₂” formed by conventional means in theupper stomach portion “u” to the position shown in FIG. 12. The forcepsmay be introduced through the opening “o” (FIG. 8) created in the bowelportion “b₁” and maneuvered to grasp anvil rod 46 and pull the anvil rod46 through the opening. In accordance with this procedure, the stapleholding component 106 of the instrument 100 is introduced within theopening “o” after accessing anvil rod 46 of anvil rod 32. It is alsoenvisioned that anvil rod 46 may include a sharpened tip which ismanipulated to pierce the stomach tissue to connect to the circularanastomosis instrument 100. Alternatively, the sharpened anvil rod 46may be passed through the staple lines S_(1a), S_(2b).

With reference now to FIGS. 13-14, anvil rod 46 is grasped withconventional forceps inserted through a trocar (not shown) andpositioned such that anvil rod 46 is adjacent the circular anastomosisinstrument 100. Thereafter, anvil rod 46 is inserted within the circularanastomosis instrument 100 to be mechanically coupled therewith. Anvilrod 46 is thereafter approximated as is conventional and the instrumentis fired. As a result of the firing of the instrument 100, a circulararray of staples are advanced through the bowel section “b₂” and upperstomach tissue to join the marginal tissue portions of the upper portion“u” and the small bowel portion “b₂”. In addition, a circular knife ofthe anastomosis instrument 100 defines an annular opening between thetissue sections to fluidly connect the interior of the upper stomachportion “u” and the lumen of the bowel portion “b₂”. Thereafter, theanvil 34 is detached from the circular anastomosis instrument 100 andthe delivery instrument with attached anvil 32 is removed through theesophagus “e”, i.e., in the direction “B” opposite to the insertiondirection “A” shown in FIG. 8.

With reference now to FIG. 15, attention is now directed to rejoiningthe bowel sections “b₁”, “b₂”. In one preferred method, bowel sections“b₁”, “b₂” are positioned in juxtaposed side by side relation and joinedwith the use of the linear stapler instrument 200 of FIG. 6.Specifically, the instrument 200 is introduced within a trocar “t”accessing the abdominal area. Thereafter, cartridge assembly 206 isintroduced within the end of bowel section “b₁” through the staple lineS_(2a). An opening “o” is made in the wall of bowel section “b₂”followed by insertion of anvil 208 within the opening “o” and into thelumen of bowel section “b₂”. The instrument 200 is approximated andfired to connect the bowel sections “b₁”, “b₂” with rows of stapleswhereby the knife blade severs tissue between adjacent staple rows toconnect the lumens of the bowel sections “b₁”, “b₂”. The instrument 200is removed and the opening in the wall of the bowel section “b₂” isclosed.

In an alternate procedure depicted in FIG. 16, the circular anastomosisinstrument 100 of FIG. 5 is positioned through a trocar “t” accessingthe abdominal cavity. The closed stapled end “S_(2a)” of bowel section“b₁” is positioned against the wall of bowel section “b₂”. Thereafter,an access opening “o” is formed in one of the bowel sections, e.g.,bowel section “b₁” , and the staple holding component 106 with mountedanvil 32 is introduced within the opening “o”. The instrument 100 isadvanced to pass the anvil head 44 through an opening formed (byconventional techniques) in the bowel section “b₂” to position the anvilhead 44 within the lumen of the bowel section “b₂”. Anvil head 44 isthereafter approximated and the instrument 100 is fired to join themarginal tissue portions of bowel sections “b₁”, “b₂” while the circularknife of the instrument 100 resects the tissue to connect the respectivelumens of the sections “b₁”, “b₂”.

Thus, in accordance with the apparatus and method of the presentdisclosure, the stomach is reduced significantly in size while thenormal digestive path of the intestinal tract is maintained therebyproviding an effective treatment for obesity. The preferred surgicalapproach is minimally invasive which significantly reduces patienttrauma and recovery time.

Referring now to FIG. 17, alternative bypass procedures to be performedin the digestive system in accordance with the instrumentation andmethod of the present invention are illustrated. In addition to theaforementioned gastric bypass procedure connecting the upper stomachsection “u” adjacent staple line S₁ with the small bowel adjacent stapleline S₂, described in connection with FIGS. 7-16, other preferred bypassprocedures are envisioned. For example, it is envisioned that a portionof the esophagus and stomach may be resected adjacent staple lines S₄,S₅, respectively and subsequently rejoined adjacent the staple linesS₄,S₅ in a bypass procedure. More specifically, a staple line S₅ isformed within the intermediate stomach section in the manner asdiscussed above in connection with FIGS. 7-15. Another staple line S₄ isformed at the lower end of the esophagus. This staple line S₄ may becreated through a trocar and with the stapling instrument 200 of FIG. 6in a manner similar to that described above. The resected esophageal andstomach tissue (i.e., between the staple lines S₄, S₅) is removed.Apparatus 10 is introduced into the esophagus and the anvil 32 isdeployed and manipulated through an opening (not shown) adjacent stapleline S₅. The circular anastomosis instrument 100 is then introduced intothe stomach portion below staple line S₅ followed by connection of theanastomosis instrument 100 and the anvil 32 as discussed above. Thetissue is approximated and the instrument is fired to connect theesophageal section adjacent staple line S₄ with the stomach sectionadjacent staple line S₅. Anvil 32 is then disconnected from anastomosisinstrument 100 and removed, thereby completing the procedure.

One skilled in the art may readily adapt the preferred method ofperforming additional bypass procedures in the digestive system whichincludes, but is not limited to connecting a stomach section defined bystaple lines S₁ or S₅ to an intestinal section defined by staples linesS₂ or S₆; connecting an esophageal section defined by staple lines S₃ orS₄ to a stomach section defined along staple lines S₁ or S₅; connectingan esophageal section along staple lines S₃ or S₄ to an intestinalsection defined along staple lines S₂ or S₆; or connecting stomachsections along staple lines S₁,S₅. While staple lines S₁-S₆ are shown asprecise lines, it understand that their positions in FIG. 16 arerepresentative, for the purposes of illustrating the bypass procedure ina digestive system, and are capable of being modified within thatprocedure for each individual application by one skilled in the art.Similarly, the anastomosis instrument 100, endoscopic linear staplinginstrument 200, and anvil 32 are representative instruments that can besubstituted for by one or more similar devices that perform similarfunctions.

Referring now to FIGS. 18-19, there is illustrated an alternateembodiment of the apparatus 10 of FIGS. 1-4, for delivering an anvil inconjunction with the laparoscopic digestive bypass procedure of thepresent disclosure. Apparatus 300 includes an outer sheath 302, anvildelivery member 304 disposed within the outer sheath 302 and an anvilcomponent 306 mounted within the outer sheath 302. Delivery member 304includes proximal disc-shaped handle 308 which is advanced to move anvilcomponent 306 between an initial position (FIG. 18) disposed withinouter sheath 302, and an advanced position (FIG. 19) where the anvil 306is fully ejected from the outer sheath 302. Apparatus 300 furtherincludes a bull-nosed shaped cap 310 which is mounted to the proximalend of anvil rod 312 to cover the anvil rod 312 during passage throughthe esophagus. Cap 310 is preferably fabricated from a bioabsorbablepolymer such that subsequent to deployment of anvil component 306 fromouter sheath 302, the cap 310 may be removed from anvil rod 312 to beleft for absorption into the body.

Referring now to FIGS. 20-22, there is illustrated another alternateembodiment of the apparatus 10 of FIG. 1. In accordance with thisembodiment, apparatus 400 includes an anvil component 402 which ispivotally mounted to delivery member 404 through pivot connection 406thereby providing a pivotal range of motion of approximately 180°. Inaddition, anvil head 408 of anvil component 402 is pivotally mounted toanvil rod 410 through pivot pin 412 and thus pivots relative to anvilrod 410 through a 180° range of motion. This facilitates positioning ofanvil component 402 relative to the end to end anastomosis instrument100. In addition, this arrangement significantly reduces the overallprofile of anvil component 402 thereby enhancing ejection of the anvilcomponent 402 from the outer sheath (not shown) and passage through theesophageal tract. In particular, when positioned in the outer sheath(not shown), anvil head 408 is in the arrangement of FIG. 21 pivoted ina non-operative position, i.e., ninety degrees (90°), with respect tothe axis of anvil rod 410. Subject to deployment in the desireddigestive tissue, e.g., the upper stomach section “u”, anvil component402 is mounted to the anastomosis instrument 100 of FIG. 5 in theaforedescribed manner. Thereafter, anvil head 408 is pivoted to theproper operative orientation (FIG. 22) with respect to the stapleholding component 106 of the circular anastomosis instrument 100 bypulling delivery member 404 in the proximal direction.

Referring now to FIGS. 23-28, there is illustrated another alternateembodiment of the apparatus for performing a laparoscopic gastric bypassprocedure in accordance with the principles of the present disclosure.Apparatus 500 may include outer sheath or guide member (not shown) whichmay be similar to the configuration of the outer guide 12 of theapparatus 10 of FIG. 1 or the configuration of the outer sheath 302 ofthe apparatus of FIG. 18. Alternatively, and in the preferredembodiment, no outer sheath is incorporated in apparatus 500. Apparatus500 further includes delivery member 502 defining longitudinal opening504, pivot element 506 at least partially disposed within thelongitudinal opening 504 and anvil component 508 connected to thedelivery member 502. Delivery member 502 defines disc-shaped handle 510at its proximal end which is advantageously dimensioned for engagementby the user. Delivery member 502 and pivot element 506 are preferablysufficient in length to extend from the upper stomach section throughthe esophageal tract and out the mouth or oral cavity.

Pivot element 506 includes manually engageable portion or button 512 atits proximal end and pivot link 514 which is connected to the button 512and extends distally therefrom. Pivot link 514 is connected to the anvilhead 516 of anvil component 508 through pin 518. In the preferredembodiment, 506 pivot element includes proximal and distal link portions506 a, 506 b connected to each other through pin 520, however, it isenvisioned that pivot element 506 may be a single component.

Pivot element 506 is adapted for reciprocal longitudinal movement withindelivery member 502 between an initial position (FIG. 25) and anactuated (or retracted) position to cause corresponding pivotal movementof the anvil head 516 of the anvil component 508. Pivot element 506 isnormally biased to the actuated position by coil spring 522. Coil spring522 is mounted within the interior of disc-shaped handle 510 and engagesat one end, interior wall surface 524 of the handle 510 and, at itsother end, abutment surface 526 of button 512. Pivot element 506 isreleasably locked in its initial position against the bias of coilspring 522 by a locking mechanism. In the preferred embodiment, alocking ring 528 is mounted within a circumferential recess 530 at theproximal end of handle 510 of delivery member 502. Locking ring 528defines an internal locking shelf 532. Similarly, button 512 of pivotelement 506 includes a corresponding locking shelf 534 which engages theshelf 532 of locking ring 528 to releasably lock the pivot element 506in the initial position. To release button 512, the button 512 is movedaway from locking shelf in a radial direction, i.e., toward the leftwith respect to FIG. 24. It is noted that a sufficient clearance existsbetween the outer surface 536 of button 512 and the interior surface oflocking ring 528 to permit such radial movement of the button 512. Oncereleased, pivot element 506 moves rearwardly under the influence of coilspring 522 to cause the pivotal anvil head 516 of anvil component 508 topivot to the operative position of FIG. 27.

With reference to FIG. 28, in conjunction with FIGS. 23-27, furtherdetails of anvil component 508 will be discussed. Anvil component 508includes anvil rod 538 and the anvil head 516 pivotally mounted to theanvil rod 538 through pivot pin 540. Anvil head 516 is arranged inoblique relation relative to the axis of the delivery member 502 when inthe initial position of the pivot element 506. Such arrangementsignificantly reduces the overall profile of anvil component 508,thereby reducing the overall diameter requirement of the outer sheath.This significantly facilitates passage of the apparatus through therestricted lumen of the esophageal tract.

Anvil component 508 has an adapter assembly 542 mounted to the end ofthe anvil rod 538 opposite anvil head 516. Adapter assembly 542 includesan adapter rod 544 defining a longitudinal opening 546 at one end toreceive anvil rod 538 of anvil component 508. Preferably, thelongitudinal opening 546 of adapter assembly 542 is correspondinglydimensioned such that the assembly 542 forms a snap-fit about theentrance end of anvil rod 538 to mount the anvil rod 538 to the adapterassembly 542. Adapter assembly 542 is preferably connected to theanastomosis instrument 100 (FIG. 5) and then is subsequently connectedto anvil component 508 after the instruments have been introduced intothe surgical site, i.e., adapter assembly 542 is not connected to anvilcomponent 508 prior to introduction of the instrument 500 into theesophagus. It is noted that in FIGS. 23-28 adapter 542 is shown mountedto anvil rod 538 for illustrative purposes. Alternatively, the anviladapter 542 may be first attached to anvil rod 538 after introductioninto the surgical site and then connected to the anastomosis instrument100. The use of adapter assembly 542 permits anvil rod 538 to besignificantly reduced in size and diameter, thereby facilitating passageof the instrument 500 and anvil component 508 through the esophagus, andmanipulation about the surgical site. Further details of the adapterassembly will be discussed in connection with the embodiment of FIG. 29.

In use, in connection with the method of FIGS. 7-16, apparatus 500 withmounted anvil component 508 is introduced through the esophageal tractand advanced within the upper stomach section “u” (FIG. 8). Circularanastomosis instrument 100 with mounted adapter assembly 542 isintroduced within bowel section “b₂” (FIG. 8). Anvil rod 538 is thenconnected to anvil adapter 542 in the aforedescribed manner.Alternatively, anvil adapter 542 is first connected to anvil rod 538followed by connection of the anvil adapter 542 to the circularanastomosis instrument 100. Button 512 of instrument 500 is thenreleased to permit pivoting element 506 to move proximally under thebias of coil spring 522. Upon proximal movement of pivot element 506,anvil head 516 pivots to its operative position (FIG. 27) whereby theanvil surface is transverse to anvil rod 538. Anvil component 508 andstaple holding component 106 of instrument 100 are approximated and theinstrument is fired to connect the tissue sections “b₁”, “b₂”. Uponcompletion, anvil rod 538 is disconnected from adapter assembly 542 andapparatus 100 with mounted anvil component 508 is removed through theesophageal tract. Prior to removal, anvil head 516 is preferably pivotedand locked in its non-operative position by depressing button 512.

Referring now to FIG. 29, there is illustrated another alternateembodiment of the present disclosure. System 600 includes deliveryinstrument 602, anvil component 604 and catheter guide 606 which isreleasably connected to the anvil component 604. Delivery apparatus 602is substantially similar to the apparatus 500 described in connectionwith FIGS. 23-28, and reference is made thereto for the particulars ofits operating mechanisms. Anvil component 604 is also similar to theanvil component 508 of FIGS. 23-28. However, in accordance with thisembodiment and as best depicted in FIG. 30, anvil component 604 furtherincludes suture unit 608. Suture unit 608 functions in connectingdelivery instrument 102 with catheter guide 606. A suture 612 is passedthrough aperture 614 of anvil rod 616, through opening 618 in adepending surface of anvil head 610, and back through the aperture 614of the anvil rod 616 in a race track arrangement. As depicted in FIGS.30-31, the free ends of the suture 610 are connected by conventionalmeans to an externally threaded collar 622 which is subsequentlyconnected to catheter guide 606 as will be discussed. The suture 610 issufficiently taut upon assembly so as to facilitate retention of theanvil head 610 in the pivoted non-operative position.

With reference to FIGS. 32A and 32B, anvil rod 616 is specificallyadapted for non-invasive transport through the restricted esophagealpassageway. More particularly, anvil rod 616 is substantially reduced inlength and in cross-sectional dimension as compared to conventionalanvil rods used with circular anastomosis instruments. The length “l” ofanvil rod 616 ranges from about 1.50 inches to about 1.90 inches, andthe maximum diameter “d” ranges from about 0.17 inches to about 0.21inches. In the preferred embodiment, the length “l” is about 1.79 inchesand the maximum diameter “d” is about 0.19 inches. This represents areduction in length and diameter relative to a conventional anvil rod ofabout 45%, and about 57%, respectively.

Anvil component 604 is coupled to the circular anastomosis instrumentthrough anvil adapter 618. With reference to FIGS. 33-35, anvil adapter618 includes adapter rod 620 having tapered mounting portion 622 at oneend for connection to the circular anastomosis instrument and externalsplines 624 to engage corresponding internal splines/grooves of thecircular anastomosis instrument 100. The connection of anvil adapter 618is similar to the connection of the anvil to the USSC PREMIUM CEEA™instrument as disclosed in U.S. Pat. Nos. 5,119,983 or 5,718,360. Asbest depicted in FIGS. 33-34, an axial opening 626 adjacent the secondend of adapter rod 620 extends to an intermediate portion of the rod620. The axial opening 626 is defined by inwardly tapered walls 628which extend into an enlarged inner cavity 630 of the opening. Thejuncture of the tapered walls 628 and inner cavity 630 defines anabutment surface 632. A plurality of internal splines 634 are disposedadjacent the second end of anvil rod 616 and extend in a generallongitudinal direction. Upon assembly of anvil rod 616 and adapter 620,the tapered portion 617 of anvil rod is inserted within axial opening626 of the adapter 618. As the rod 616 is advanced in the adapter 618and passed through the narrowed opening defined by inner tapered walls628, the tapered walls 628 are biased outwardly in a spring-like mannerto permit passage of the tapered mounting portion 617 therethroughwhereby upon clearance, the anvil rod 616 is locked within the adapter618 by engagement of the tapered mounting portion 617 of the anvil rodwith abutment surface 632 of adapter 618. During insertion, the externalsplines 624 of anvil rod are preferably aligned with the internalsplines 634 of adapter 618 so as to received in interdigitatingrelation, thereby also rotationally fixing the anvil rod with respect tothe adapter. As discussed hereinabove, the anvil adapter 618 permits theuse of the reduced dimensioned anvil rod 616.

With reference again to FIG. 29, catheter guide 606 of apparatus 600includes flexible outer member 636 which is preferably fabricated from asuitable polymeric material and defines a longitudinal bore 638 (shownin phantom) extending therethrough. Outer member 636 ranges in lengthfrom about 36 inches to about 60 inches to at least extend from theresected upper stomach section through the esophagus and out the mouthfor engagement by the user. The distal end of outer member 636 ispreformed to define an arched or curved section 640. Such configurationfacilitates manipulation and passage of catheter guide 606 through theesophagus and into the resected upper stomach portion. An atraumatic tip642 is mounted to the distal end of outer member 636 and a couplermember 644 is attached to the proximal end of the outer member. Asdepicted in FIG. 31, the coupler member 644 includes an internal thread646 at its proximal end which receives the externally threaded collar622 of suture unit 608 to operatively connect the delivery apparatus 602and the catheter guide 606. Coupler member 644 is preferablyrotationally mounted about outer member 636 to facilitate threadedengagement of the coupler and collar members 644, 622. Catheter guide606 may further include a guide wire which is receivable within thelongitudinal opening of the outer member 636. Preferably, the guide wireis sufficient in length to extend from the distal end portion of theouter guide to the proximal end for engagement by the user. However, itis to be appreciated that the use of a guide wire is optional.

The use of the apparatus 600 will now be discussed. The upper stomachsection “u” and the bowel “b₂” are resected in the manner discussedhereinabove in connection with FIGS. 7 and 8. With reference now to FIG.36, initially, the catheter guide 606 and inserted guide wire “w”, ifused, is introduced within the oral cavity and passed through theesophageal passage “e” to be advanced within the upper stomach portion“u”. It is noted that the curved distal portion 640-of the outer member636 facilitates passage of the catheter guide 606 through manualmanipulation and rotation of the outer member 636. Once the distal endof the outer member 636 accesses the upper stomach portion “u”, theguide wire “w” is removed by retracting the guide wire in a proximaldirection through the oral cavity. The delivery instrument 602 is thenconnected to the proximal end of the catheter guide 606 which extendsfrom the mouth through the threaded interconnection of collar 622 ofanvil component 604 and the coupler 644 of outer member 636 as discussedabove.

With reference to FIG. 37, the surgeon then accesses the distal end ofouter member 636 through an incision “o” or trocar accessing the upperstomach portion “u” and pulls the entire system 600 through theesophagus “e” in the direction of directional arrow “A”. Accordingly,the anvil component 604 and attached delivery instrument 602 are passedthrough the esophageal tract “c”. It is noted that the anvil head 610 isin its pivoted non-operative position to facilitate passage through thetract. The surgeon continues to advance the components until anvilcomponent 604 is within the upper stomach section “u” and visible to thesurgeon. Thereafter, the suture unit 608 attached to anvil component 604is severed and removed from the anvil component 604, which therebydisconnects catheter guide 606 from the anvil component 604. Thecatheter guide 606 is discarded.

With reference to FIG. 38, bowel section “b₂” is positioned adjacentupper stomach section “u”. A trocar “t” is introduced within an opening“o” in the bowel section “b₂”. The circular anastomosis instrument 100with attached adapter 618 is inserted in the trocar “t” and through anopening in the upper stomach portion “u”.

Anvil adapter 618 is then mounted to anvil rod 616 of the anvilcomponent 608. Delivery instrument 602 which extends through theesophagus such that its proximal end is exposed from the mouth is thenactuated in the manner described in connection with the embodiment ofFIGS. 23-28 to pivot the anvil head 610 to the operative position. Thecircular anastomosis instrument 100 and anvil head 610 are approximatedand the instrument 100 fired to join the tissue portions in a mannerpreviously described.

With reference to FIG. 39, anvil component 604 is released from anviladapter 618. Delivery instrument 602 is actuated to return the anvilhead to the pivoted non-operative position. Thereafter, deliveryinstrument 602 with attached anvil component 604 is removed back throughthe esophagus and mouth in the direction B of FIG. 39.

Referring now to FIGS. 40-42, there is illustrated another alternateembodiment of the present disclosure. System 700 includes deliveryinstrument 702 and anvil assembly 704 releasably mounted to the deliveryinstrument 702. Anvil assembly 704 is substantially similar to the anvilassembly 604 described in connection with the embodiment of FIGS. 23-30,and reference is made thereto for particulars of the anvil assembly.Delivery instrument 702 includes handle 706 having handle half sections706 a, b attached to each other through adhesive screws, or the like,and elongated sleeve 708 connected to the handle 706 and extendingdistally therefrom. In a preferred embodiment, handle 706 includesexternally threaded collar 710 mounted within the interior of the handle706, which threadably engages corresponding internal threaded portion710 of the elongated sleeve 708 to connect the two components. Othermeans for connecting are envisioned, including bayonet coupling,adhesives, etc. Handle 706 further possesses proximally positionedbutton 714 which functions to actuate a pivot mechanism for pivoting theanvil assembly 704, and manually engageable release button 716 whichactuates a release mechanism for releasing anvil assembly 704 from theanastomosis instrument. The pivot and release mechanisms will bediscussed in greater detail hereinbelow.

With reference now to FIGS. 41-43, the pivot mechanism is substantiallysimilar to the pivot mechanism of the embodiment of FIG. 29 and includespivot element 718 extending from button 714, and pivot rod 720 which isconnected to the pivot element 718. Button 714 and pivot element 718 maybe monolithically formed as a single unit as shown in the Figures. Pivotelement 718 defines a semicircular open section 722 at its distal end toreceive the proximal end of pivot rod 720. An internal circumferentialrib 724 is integrally formed within the semicircular section 722 and issnap-fit into a circumferential groove 726 of pivot rod 720 to connectthe two components.

The pivot mechanism further includes pivot link 728 which is received ina groove 730 defined at the distal end of pivot rod 720. Pivot link 728is pivotally connected to pivot rod 720 through pin 732 and is furtherconnected to anvil head 610 of anvil assembly through pin 734. The pivotmechanism moves in a longitudinal direction to cause correspondingpivotal movement of anvil head 610 between an operative position (FIG.42) and a pivoted position (FIG. 43). The pivot mechanism is springbiased in the proximal direction corresponding to the operative position(FIG. 42) of the anvil assembly by coil spring 736. Coil spring 736 iscoaxially arranged about pivot element 718 and engages, at its proximalend, abutment surface 738 of the pivot element 718 and, at its distalend, collar 740. Collar 740 is fixedly connected to the interior ofhandle portions 706 a, b adjacent interior wall 741 of the handle 706.With this arrangement, coil spring 736 normally biases pivot element 718and pivot button 714 in the proximal direction. The pivot mechanism maybe releasably locked in the non-operative position by applying a radialdirected force “r” to pivot button 714 to radially displace the buttonto the position depicted in FIG. 43. In this position, a locking shelf714 a of pivot button 714 engages a corresponding locking wall 707 ofhandle 706. Release of the pivot button 714 may be accomplished byradially displacing the pivot button 714 to its normal aligned positionof FIG. 42.

With continued reference to FIGS. 40-43, the release mechanism forreleasing anvil assembly 709 from its mounting to the end-to-endanastomosis instrument will be discussed. The release mechanism includesthe aforementioned release button 716, release collar 742 disposedwithin handle 706 and flexible release link 744 connected to the releasecollar 742 and extending distally to the anvil assembly 704. Releasecollar 742 defines an internal longitudinal bore 746 dimensioned toreceive pivot element 718 of the pivot mechanism and permit reciprocalslidable longitudinal movement of the pivot element therewithin. Releasecollar 742 is fixed to release button 714 through corresponding mountingstructure of the two components, e.g., tongue and groove arrangement,identified generally by reference numeral 748 in FIGS. 42-43. Releaselink 744, in turn, is operatively connected to release collar 742through set screw 750 which is positioned to securely engage theproximal end of the release link 744. Set screw 750 also permits theoperator to adjust the positioning of the release link 744 relative tothe release button 716 to account for manufacturing tolerances, etc.

As best depicted in FIGS. 42-43, release link 744 is connected at itsdistal end to anvil release collar 752 which is coaxially positionedabout the anvil rod 616 of anvil assembly 704. Such connection may beaccomplished via conventional means, including adhesives or the like.Anvil release collar 752 moves relative to the anvil rod 616 uponcorresponding longitudinal movement of release link 744 to thereby causerelease of the anvil rod 616 relative to the anastomosis instrument, aswill be discussed. The release mechanism is biased in a proximaldirection by coil spring 754. Coil spring 754 engages, at its distalend, abutment wall 756 of handle 706 and engages, at its proximal end,abutment surface 758 of release collar 742 to normally bias the releasecollar 742 to the unactuated position depicted in FIG. 42. As shown inFIG. 44, the release mechanism is activated by advancing release button716 distally against the influence of spring 754 which causescorresponding distal movement of release collar 742, release link 744and anvil release collar 752. The relationship of anvil release collar752 and anvil assembly 704 will be discussed hereinbelow.

Referring now to FIGS. 45-48, system 700 further includes light guide760. Light guide or cable 760 is initially introduced through theesophagus to illuminate and/or visually inspect the operative site.Light guide 760 includes handle 762 and fibre cable 764 which extendsdistally from the handle 762. Handle 762 includes two distinct members,namely, proximal cap 766 and distal collar 768. Distal collar 768defines a longitudinal bore 770 for reception of the proximal end offiber cable 764 and is fixed to the fiber cable 764 by conventionalmeans, including adhesives, crimping, etc. Distal collar 768 furtherincludes an external threaded portion 772. Proximal cap 766 defines alongitudinal opening 774 and an internal threaded portion 776 whichthreadably engages the external threaded portion 772 of the distalcollar 768 to connect the components.

Fiber cable 764 may be a single optical fiber as shown, or a pluralityor bundle of fibers as appreciated by one skilled in the art. Theoptical fiber may be comprised of optical glass or polymeric matter.Fiber cable 764 extends to distal independent lens 778 which serves tofocus the light emitted by the fiber cable 764. A collar 779 disposedadjacent the distal end of the fiber cable 764 mechanically couples theoptical fiber and lens 778. Fiber cable 764 is connectable to aconventional light source “s” depicted in FIG. 45. Preferably, distalcollar or adapter 768 is coupled to the light source in a conventionalmanner. Proximal cap 766 is attachable to the anvil assembly 704 throughsuture “s” (FIG. 46) as will be discussed.

With reference now to FIGS. 49-51, there is illustrated an embodiment ofan anvil adapter 780 which is to be utilized with the system 700 of thepresent invention. Anvil adapter 780 couples anvil assembly 704 to thecircular anastomosis instrument (FIG. 5) utilized in accordance with thepreferred surgical procedure. The anvil adapter 780 permits the use ofan anvil rod which is significantly reduced in diameter and length asdiscussed in connection with the embodiment of FIG. 29 to facilitatepassage of the anvil assembly through the esophagus. Anvil adapter 780includes adapter rod 782 having tapered mounting portion 784 forconnection to the anastomosis instrument. The end of adapter rod 782opposite the mounting portion 784 includes a jaw mechanism 786 whichcouples with anvil rod 616 of the anvil assembly 704 to connect theanvil adapter 780 and the anvil assembly 704. Adapter rod 782 defines acentral longitudinal bore 788 which extends to form slots 790 in opposedwall portions of the rod 782 as shown in FIG. 49. The jaw mechanismincludes first and second opposed jaws 792 pivotally mounted withinlongitudinal bore 788 of adapter rod 782 through pivot pin 794 andextending through the slots 790 of the adapter rod 782. Jaws 792 movebetween an engaged position with respect to anvil rod 616 (FIG. 50) toengage the anvil rod 616 and a release position to release the anvil rod616 as will be discussed.

Anvil adapter 780 further includes plunger 796 which is mounted withinlongitudinal bore 788. Plunger 796 is normally biased toward opposedjaws 792 by coil spring 798 which is coaxially mounted about one endportion of the plunger 796. The other end portion of plunger 796 definesan enlarged cylindrical head 800. Head 800 of plunger 796 normallyengages under the influence of coil spring 798, inclined cammingsurfaces 802 of jaws 792 to bias the jaws 792 to the closed positiondepicted in FIGS. 50 and 51.

Anvil adapter 780 further includes ejector plate 804 disposed within thecentral longitudinal bore 788 adjacent plunger 796. Ejector plate 804has an enlarged head 806 which is received within cylindrical opening808 of plunger head 800, and an elongated portion 810 depending from thehead 806. Elongated portion 810 has a longitudinal bore 812 whichaccommodates pivot pin 794 of the jaw mechanism. Ejector plate 804 isnormally biased toward jaws 792 by coil spring 814 which is disposed ina longitudinal opening 816 of plunger 796. When anvil 616 is securedwithin anvil adapter 780, coil spring 814 is compressed throughengagement of the distal tip 616 t of anvil rod 616 and elongatedportion 810 of ejector plate 804. Ejector plate 804 is adapted forlimited longitudinal movement relative to adapter rod 782 to release theanvil adapter 780 from the anvil. In particular, anvil adapter 780 isreleased from anvil rod 616 of anvil assembly 704 by advancing releasebutton 716 to the distal position of FIG. 44 which advances releasecollar 742, release link 744 and anvil release collar 752. Withreference to FIGS. 52-53, as anvil release collar 752 advances, cammingsurfaces 752 a of release collar 752 engage inner inclined surfaces 792a of jaws 792 to radially displace the jaws to the position depicted inFIG. 53. Once the jaws 792 clear the vertical surface 616 a of anvil rod616 adjacent the tapered mounting portion, the anvil rod 616 may bedisengaged. Disengagement is facilitated through interaction of coilspring 814 and ejector plate 804 which moves proximally under influenceof the compressed coil spring 814 to expel the anvil rod 616 in aproximal direction and released from the jaws 792 as detailed in FIG.53. Thus, as appreciated, the releasing mechanism provides a positiveexpulsion force to eject anvil rod 616 from the anvil adapter 780thereby obviating the need of the surgeon to forcibly separate the twocomponents.

The use of system 700 will now be discussed. The upper stomach section“u” and the bowel “b₂” are resected in the manner discussed hereinabovein connection with FIGS. 7 and 8. Light guide 760 is then advancedthrough a gastric tube (not shown) positioned in the esophagus to beadvanced within the upper stomach section “u” in a similar manner tothat described in connection with insertion of the guide wire “w” ofFIG. 36. The light guide 760 is then energized whereby light emitted bythe guide 760 is focused on the interior wall of the upper stomachsection “u”. The focused light provides a visual indicator to thesurgeon as to location of the light guide 760 so as to guide the surgeonin forming the incision in the wall of the upper stomach section “u”.The incision is preferably formed adjacent the lit area of the stomachwall such that subsequent to creating the incision, the surgeon cangrasp the distal end of the light guide 760. The light guide isdisconnected from the light source. The delivery instrument 702 withmounted anvil assembly 704 is connected to the proximal end of the lightguide. With reference to FIG. 47, in accordance with the preferredprocedure, proximal cap 766 of light guide 760 is connected to anvilassembly 704 with a suture “s” which is looped through the eye loop 766a of the cap 766 and passed through the aperture “a” of anvil rod 616 ina similar manner to that shown and described in connection with FIGS. 29and 30. It is noted that in accordance with this embodiment, the suture“s” is not required to be looped through the anvil head 610 of the anvilas shown in FIG. 29 in that the anvil head 610 is releasably locked inthe pivoted position as discussed hereinabove. With the anvil assembly704 connected to the proximal end of the light guide 760, the lightguide 760, anvil assembly 704 and mounted delivery instrument 702 ispulled through the esophagus in a similar manner to that described inconnection with FIG. 37.

The surgeon continues to advance the components until anvil component700 is within the upper stomach section “u” and visible to the surgeon.Thereafter, the suture attached to anvil assembly 704 is severed andremoved, thereby detaching light guide 760 which is then removed.

The bowel section “b₂” is positioned with respect to the upper stomachsection “u”, and the circular anastomosis instrument with attachedadapter 780 is inserted through the trocar in the same manner detailedin connection with the discussion of FIG. 38. The anvil rod 616 of theanvil assembly 704 is grasped with a grasping instrument. For example,FIGS. 54-55 illustrate a novel grasping forceps which can facilitategripping engagement of the anvil rod 616. This forceps is disclosed incommonly assigned provisional application entitled SURGICAL JAWS, mailedMar. 5, 2001 under Express Mail Certificate No. EL 765221053 US, thecontents of which is incorporated herein by reference. The forceps jaws900 permit grasping of the anvil rod 616 from a substantially aligneddirect near zero degree approach.

The anvil rod 616 is then mounted within anvil adapter 780 by advancinganvil rod 616 between jaws 792 of the anvil adapter 780 whereby uponinsertion the jaws 792 are displaced outwardly. Once the mountingportion of anvil rod clears the jaws 792, the jaws 792 return to theirnormal position under the influence of coil spring 798 and plunger 796whereby the jaws 792 engage the vertical surface 616 a of the anvil rod616 to effectuate mounting of the anvil rod 616 to the anvil adapter 780(FIG. 50).

Delivery instrument 702 may then be activated by releasing button 714 topermit the button 714 to return under the influence of coil spring 736to its normal position of FIG. 42 thereby causing corresponding proximalmovement of pivot rod 720 and pivot link 728 which pivots anvil head 610to the operative position. The circular anastomosis instrument and anvilassembly are thereafter approximated and the instrument is fired to jointhe tissue portions.

The release mechanism is thereafter actuated to release anvil rod 616from anvil adapter 780 in the manner discussed above. Deliveryinstrument is activated to return anvil head 610 to the pivotednon-operative position. The delivery instrument 702 and anvil assembly704 are removed through the esophagus “e”.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision other modifications within the scopeand spirit of the claims appended hereto.

1-35. (canceled)
 36. A method for performing a bypass procedure in adigestive system, comprising the steps of: isolating an upper stomachportion of the stomach of a patient; resecting the bowel to define abowel portion disconnected from the stomach; and connecting the bowelportion and the upper stomach portion.
 37. The method according to claim36 wherein the step of connecting is performed with an end to endanastomosis instrument.
 38. The method according to claim 37 furtherincluding the step of introducing an anvil adapted for use with theanastomosis instrument through an esophagus and into the upper stomachportion.
 39. The method according to claim 38 further including the stepof inserting an end to end anastomosis instrument into the bowelportion.
 40. The method according to claim 39 further including the stepof connecting the anvil and the end to end anastomosis instrument, andfiring the end to end anastomosis instrument to connect the bowelportion and the upper stomach portion.
 41. The method according to claim40 wherein the step of isolating includes positioning a linear staplerinstrument about the stomach and firing the linear stapler to isolatethe upper stomach portion with resect to the remainder of the stomach.42. The method according to claim 41 wherein the step of resectingincludes positioning a linear stapler about the small bowel and firingthe linear stapler.
 43. The method according to claim 42 wherein thelinear stapler has a knife blade associated therewith and wherein thestep of firing actuates the knife blade to resect the bowel to definethe bowel portion.
 44. The method according to claim 35 wherein each ofthe steps of isolating, resecting and connecting is performedlaparoscopically.
 45. A method for performing a bypass procedure in adigestive system comprising the steps of: accessing digestive tissueportions of a digestive system; advancing an anvil through the esophagusand into the first digestive tissue portion; inserting an anastomosisinstrument into the second digestive tissue portion; connecting theanvil with the anastomosis instrument and firing the anastomosisinstrument to connect the first and second digestive tissue portions;disconnecting the anvil from the anastomosis instrument; and withdrawingthe anvil through the esophagus.
 46. The method according to claim 45,further including the step of manipulating the anvil from a proximallocation outside the body to facilitate connecting of the anvil with theanastomosis instrument.
 47. The method according to claim 46, whereinthe anvil is mounted to a support member and wherein the step ofadvancing includes passing the support member through the esophagustoward the first tissue portion.
 48. The method according to claim 47,wherein the step of withdrawing includes removing the support member andanvil through the esophagus.
 49. The method according to claim 48,wherein the step of disconnecting includes manipulating the anvil toposition the anvil for withdrawal through the esophagus.
 50. A methodfor performing a surgical bypass procedure, comprising the steps of:providing an anvil delivery mechanism including a support member, ananvil mounted to the support member, and an outer guide mounted withrespect to the support member; accessing first and second tissueportions of a digestive system; at least partially introducing the anvildelivery mechanism through the esophagus and into the first digestivetissue portion whereby the outer guide is positioned to substantiallyenclose the anvil to protect the esophagus during introduction;inserting an anastomosis instrument into the second digestive tissueportion; at least partially exposing the anvil from the outer guide ofthe insertion member; connecting the anvil to the anastomosisinstrument; and firing the anastomosis instrument to connect the firstand second digestive tissue portions.
 51. The method according to claim50, wherein the step of at least partially exposing includes actuating aremote device connected to the anvil, the remote device extending to aproximal location outside the body.
 52. The method according to claim51, wherein the step of at least partially exposing includes advancingthe remote device to advance the anvil within the outer guide. 53-81.(canceled)